NCT07554482

Brief Summary

Extranodal NK/T-cell lymphoma (ENKTCL) is an Epstein-Barr virus-associated non-Hodgkin lymphoma with high incidence in Asia and Latin America. Approximately 70% of patients present with early-stage (I-II) disease confined to the upper aerodigestive tract. Radiotherapy at 50-56 Gy is the standard curative treatment, but high-dose radiotherapy causes severe toxicities including oral mucositis and xerostomia, while radiotherapy alone yields high systemic recurrence rates. Previous studies have confirmed the efficacy of P-GEMOX induction chemotherapy, verified the feasibility of reduced-dose radiotherapy in patients achieving complete response after chemotherapy, and demonstrated the radiosensitizing effect of selinexor via inhibiting IRF3-BARD1-BRCA1-mediated DNA damage repair. Moreover, international evidence supports the efficacy of 40 Gy radiotherapy combined with chemotherapy. Accordingly, this study hypothesizes that selinexor combined with 40 Gy reduced-dose radiotherapy following P-GEMOX induction chemotherapy can achieve equivalent efficacy to standard-dose radiotherapy, while markedly decreasing radiotherapy-related toxicities. This trial innovatively applies selinexor as a radiosensitizer in ENKTCL, fulfills the unmet clinical demand for efficacy-preserving toxicity reduction, and is well supported by preliminary data.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
36mo left

Started May 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Expected
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2029

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

April 21, 2026

Last Update Submit

April 21, 2026

Conditions

Extranodal NK/T-cell Lymphoma

Keywords

extranodal NK/T-cell lymphomaselinexorXPO1 inhibitorradiotherapyreduced-dose radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Complete response (CR) rate

    CR was defined as complete response evaluated using MRI scan and PET-CT scan according to Lugano criteria.

    From the day of initiation of treatment to 8 weeks after completion of radiotherapy.

Secondary Outcomes (5)

  • Overall Response Rate (ORR)

    From the day of initiation of treatment to 8 weeks after completion of radiotherapy.

  • two-year PFS rate

    From the day of treatment as of 24 months

  • two-year OS rate

    From the day of initiation of treatment as of 24 months

  • two-year local control rate (LCR)

    From the day of initiation of treatment as of 24 months

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    From the day of initiation of treatment as of 24 months

Study Arms (1)

treatment arm

EXPERIMENTAL

Patients will first receive 4 cycles of P-GEMOX induction chemotherapy. Pegaspargase at a dose of 2500 IU/m² (maximum dose not exceeding 3750 IU) is administered via intramuscular injection on Day 1 of each 21-day cycle. Gemcitabine 1000 mg/m² is given by intravenous infusion on Day 1 and Day 8 of each 21-day cycle. Oxaliplatin 130 mg/m² is administered intravenously on Day 1 of each 21-day cycle. A total of 4 cycles will be completed. Following induction chemotherapy, patients will receive consolidation therapy consisting of selinexor combined with reduced-dose radiotherapy. Radiotherapy will be delivered at a total dose of 40 Gy in 20 fractions (2 Gy per fraction), once daily, 5 fractions per week, over 4 weeks. Radiation therapy will be performed using intensity-modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT). The target volume includes the gross tumor volume (GTV) of the primary lesion before chemotherapy, with a clinical target volume (CTV) margin ex

Drug: Pegaspargase (PEG) AsparaginaseDrug: Gemcitabine (GEM)Drug: OxaliplatinDrug: SelinexorRadiation: radiotherapy

Interventions

Pegaspargase (PEG) AsparaginaseDRUG

Pegaspargase at a dose of 2500 IU/m² (maximum dose not exceeding 3750 IU) is administered via intramuscular injection on Day 1 of each 21-day cycle for a total of 4 cycles.

treatment arm
Gemcitabine (GEM)DRUG

Gemcitabine 1000 mg/m² is given by intravenous infusion on Day 1 and Day 8 of each 21-day cycle for a total of 4 cycles.

treatment arm
OxaliplatinDRUG

Oxaliplatin 130 mg/m² is administered intravenously on Day 1 of each 21-day cycle for a total of 4 cycles.

treatment arm
SelinexorDRUG

Following induction chemotherapy, patients will receive consolidation therapy consisting of selinexor combined with reduced-dose radiotherapy. Selinexor 40 mg will be administered orally twice weekly (Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Selinexor will be given concurrently with radiotherapy for a total of 8 doses.

treatment arm
radiotherapyRADIATION

ollowing induction chemotherapy, patients will receive consolidation therapy consisting of selinexor combined with reduced-dose radiotherapy. Radiotherapy will be delivered at a total dose of 40 Gy in 20 fractions (2 Gy per fraction), once daily, 5 fractions per week, over 4 weeks. Radiation therapy will be performed using intensity-modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT). The target volume includes the gross tumor volume (GTV) of the primary lesion before chemotherapy, with a clinical target volume (CTV) margin expansion of 1-2 cm.

treatment arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 to 75 years, regardless of gender.
  • Pathologically confirmed extranodal NK/T-cell lymphoma (ENKTCL).
  • Ann Arbor stage I-II disease with primary lesion located in the nasal cavity or upper aerodigestive tract (UADT).
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
  • Treatment-naïve patients with no prior radiotherapy, chemotherapy or targeted therapy.
  • Adequate major organ function as follows:
  • Hematopoietic function: absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count (PLT) ≥100×10⁹/L, hemoglobin (Hb) ≥90 g/L.
  • Hepatic function: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN), alanine transaminase (ALT) / aspartate transaminase (AST) ≤2.5×ULN.
  • Renal function: serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance rate ≥60 mL/min.
  • Cardiac function: left ventricular ejection fraction (LVEF) ≥50%.
  • Expected overall survival ≥6 months.
  • Voluntarily sign the written informed consent form.

You may not qualify if:

  • Non-nasal type ENKTCL, or primary lesions outside the upper aerodigestive tract (UADT), including skin, gastrointestinal tract, lung and other sites.
  • Patients with Ann Arbor stage III-IV disease.
  • Central nervous system involvement.
  • History of prior malignant tumors, excluding non-melanoma skin cancer or cervical carcinoma in situ cured for more than 5 years.
  • Active infections, including active hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) infection.
  • Severe complications, such as uncontrolled diabetes mellitus and severe cardiopulmonary diseases.
  • Pregnant or lactating women.
  • Hypersensitivity or contraindication to any investigational drugs in this study.
  • Concurrent participation in other interventional clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, 100730, China

Location

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

pegaspargaseAsparaginaseGemcitabineOxaliplatinselinexorRadiotherapy

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

AmidohydrolasesHydrolasesEnzymesEnzymes and CoenzymesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic ChemicalsTherapeutics

Study Officials

  • Liang Wang

    Beijing Tongren Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Wang, M.D.

CONTACT

+861058266633wangliangtrhos@126.com

Jia Cong

CONTACT

+861058268442congjia21@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Hematology in Beijing Tongren Hospital

Study Record Dates

First Submitted

April 21, 2026

First Posted

April 28, 2026

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

April 30, 2029

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)